The Company – Syner-G Pharma Consulting, LLC:

• A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
• Adept in developing risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles
• Distinguish ourselves by our passion for creativity and innovation
• Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
• Clients include national and multinational pharmaceutical companies

The Candidate:

Syner-G Pharma, CMC Consulting is seeking an exceptional science professional to join our Regulatory Affairs team. The candidate will be responsible for supporting our Biotechnology/Pharmaceutical clients throughout the regulatory filing process, including serving as the client lead as Senior Manager of Regulatory Affairs. A successful candidate will have a proven track record of learning and applying scientific principles to solve CMC technical and project management challenges. Seeking a passion to help patients by enabling the expeditious development and approval of high-quality, life-saving medicines.

Required Activities/Experience:

• MS in Chemistry, Biology, Chemical Engineering, Pharmacy, Healthcare, Public Health, or a related field.
• 7+ years’ experience in the Authoring and review of CMC sections for NDA, BLA, IND, and IMPD
• Creation and authoring of global and regional dossiers (IND, IMPD, and Canadian QOS).
• Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
• Strategize regulatory CMC pathway for new small & large molecules
• Assess and strategize post-approval changes and relevant submission
• Authoring CMC amendments, supplements, and annual reports
• Preparing briefing documents for the health authority meetings
• Regulatory agency meeting support including meeting preparation and briefing document creation.
• Review of analytical test methods, specifications, and stability protocol/report/data
• Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product
• Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
• Sponsor consultancy regarding drug development including timeline management

Critical success factors:

• Ability to work with diverse stakeholders, both internally and at commercial contract manufacturers.
• Strong knowledge and demonstrated practice of cGMP.
• Detail-oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
• Ability to troubleshoot problems, work within a team, and independently design, develop, and execute experiments.
• Ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.